Page 19 - Devices Program News Today : Breaking News, Live Updates & Top Stories | Vimarsana

To print this article, all you need is to be registered or login on Mondaq.com. What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). ...

(1) PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The RADIANCE-HTN TRIO trial evaluated the efficacy and safe...

Share this article Share this article PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise™ Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The RADIANCE-HTN TRIO...